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Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Primary Purpose

Advanced Well-differentiated Pancreatic Neuroendocrine Tumor

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
temozolomide or dacarbazine-based chemotherapy, endostatin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Well-differentiated Pancreatic Neuroendocrine Tumor focused on measuring temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years of age and older
  2. ECOG ≤2
  3. Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
  4. Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months
  5. Disease progressed during or after last therapy
  6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  7. Disease progressed within the past 12 months。
  8. Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
  9. Adequate bone marrow, liver and renal function
  10. Life expectancy 3 months or more
  11. Patient informed consent。

Exclusion Criteria:

  1. Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
  2. 2 or more lines of prior chemotherapy。
  3. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  4. Uncontrolled infectious disease。
  5. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
  6. Uncontrolled brain or leptomeningeal metastases
  7. Patients with known hypersensitivity to temozolomide or endostatin。
  8. Patient could not take tablets。

Sites / Locations

  • Division of Medical Oncology, Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

temozolomide or dacarbazine-based chemotherapy, endostatin

Arm Description

Endostatin 15mg/d,IV infusion, d1-d14 Temozolomide 150-200mg/m2/d,p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks.

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

progression free survival
toxicities

Full Information

First Posted
April 29, 2013
Last Updated
April 12, 2017
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01845675
Brief Title
Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Official Title
Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
Keywords
temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
temozolomide or dacarbazine-based chemotherapy, endostatin
Arm Type
Experimental
Arm Description
Endostatin 15mg/d,IV infusion, d1-d14 Temozolomide 150-200mg/m2/d,p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
temozolomide or dacarbazine-based chemotherapy, endostatin
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
toxicities
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and older ECOG ≤2 Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor. Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months Disease progressed during or after last therapy Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy Disease progressed within the past 12 months。 Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated. Adequate bone marrow, liver and renal function Life expectancy 3 months or more Patient informed consent。 Exclusion Criteria: Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor. 2 or more lines of prior chemotherapy。 Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study Uncontrolled infectious disease。 Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin Uncontrolled brain or leptomeningeal metastases Patients with known hypersensitivity to temozolomide or endostatin。 Patient could not take tablets。
Facility Information:
Facility Name
Division of Medical Oncology, Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

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